ES2426414T3 - Device to open an airway - Google Patents

Abstract

A therapeutic apparatus for alleviating obstruction of the upper airway of a patient, comprising: a container (105) with one end (107) and an interim surface, wherein the end (107) is configured to settle on the chin and neck of the patient to define a chamber (125) in an external location approximately in the soft tissue intern of the patient (103) associated with the anterior triangle of the neck; a vacuum pump inlet 10 for receiving a negative pressure in the chamber (125) to apply force to a surface of the patient's neck (103) to draw the surface into the interior of the chamber (125); and a control device for controlling the force applied in an spectrum of between about 4.9 N (0.5 kg) and about 65.5 N (6.68 kg) characterized in that the end (107) comprises an elastomeric seal with wings or external extensions and when the apparatus is applied to the patient (103), the contact pressure applied to the patient's jaw (123) depends on its contact area and the contact area increases with the applied vacuum level.

Description

SCOPE OF THE INVENTION

The present invention relates generally to medical devices. More particularly, the present invention relates to a device for creating and maintaining a top airway free of obstructions.

BACKGROUND OF THE INVENTION

US 2006/0266369 A I discloses devices and methods for maintaining an open airway by applying a force to a patient's tissue in a direction between inferior, anterior and lateral.

Obstruction of the superior airway (that part of the breathing duct is outside the rib cage) can occur at any age. People who are at risk of upper airway obstruction include people with sleep apnea, people with airway tumors or foreign bodies such as aspirated food, and those with inflammatory or traumatic damage to the airway. upper air passages, which results in weakened and crushed airway walls, a state known as malacia traqueo.

The medical consequences of upper airway obstruction can be devastating: the inability to effectively ventilate the lungs quickly produces hypoxemia, a generalized state of low oxygen content in the blood. If it is not corrected, hypoxemia can cause serious injuries in their consequences can be deadly.

Snoring is a common chronic medical problem that is associated with partial episodic obstruction of the upper airways during sleep. Snoring affects millions of people around the world. Snoring can cause chronic fatigue that leads to sleep deprivation, and is considered by many people to be a serious medical problem. The sound of snoring is produced by a turbulent air flow that moves through a partial upper airway obstruction area that produces resonant vibrations in the soft tissues adjacent to the upper airway.

A percentage of people who snore also suffer from sleep apnea, another frequent and serious medical condition that is associated with episodic obstruction of the airway. In the most common type of sleep apnea, obstructive sleep apnea (OSA), an affected person experiences numerous episodes of apnea, or complete, and often a prolonged cessation of breathing occurs. Severe cases can have 100 or more apnea events per hour of sleep. OSA causes nocturnal hypoxemia, and causes cognitive impairment, drowsiness during the day, hypertension, increased risk of embolism and myocardial infarction, and insulin-resistant diabetes mellitus. If left untreated, OSA can cause premature death.

OSA is caused by the closure of the upper airway during sleep due to an alteration in the mechanical properties of the upper airway and / or to disorders in the neuromuscular control over the caliber of the airway. Alterations in the mechanical properties of the upper airway, which predispose to the collapse of the upper airway during sleep, may be large, or may be idiopathic. It has been shown that a variety of medical interventions improve the mechanical properties of the upper airway, and reduce the closure of the airway associated with sleep. These include rowing surgeries airway delation, medical devices that reposition the jaw, and continuous positive airway pressure (CPAP).

Unfortunately, all current treatments produce results that are far from optimal. Surgery and repositioning devices are effective only in a minority of OSA patients; and the answers can not be identified with certainty before starting treatment. As a result, many people undergo painful and costly procedures without any benefit. On the other hand, CPAP is effective in most OSA patients; however, the treatment is uncomfortable and is not well tolerated in its long-term use. A substantial number of patients who are given CPAP discontinue therapy within the first year after its initiation.

CPAP works by providing air at pressures above the ambient pressure to the upper airway during sleep. The application of positive pressure on the upper airway acts as an "imitator", and may retard the tendency of the upper airway to collapse during certain phases of sleep in OSA patients. In order to provide pressures above the ambient pressure on the upper airway, the patient must wear a tight mask covering the mouth and / or nose. The mask is connected to an air supply tube and a variable pressure air pump. An additional component that humidifies the air can be added, in order to avoid drying out the upper airway during the treatment. There are multiple reasons for

facial that can cause claustrophobia, noise from the air pump and

Humidity of the humidification system. Also, some ePAP units

they are not easy to transport, and they limit the ability to travel by

5

patients

Therefore, there is a pressing medical need to develop a

means to improve the obstruction of the upper airway, resulting both

highly effective as easy to tolerate during chronic use.

\OR

SUMMARY OF THE INVENTION

The needs expressed above are met in this

invention, which provides an apparatus as defined in claim 1.

Other embodiments of the invention are described in the claims

fifteen

dependents

According to an embodiment of the present invention, there is provided

a device that has a container. The container can be an empty utensil or

concave, cup-shaped, bowl or similar. The container has one end and one

external surface, and is configured to fit under the chin of a

twenty

individual, adjacent to the individual's neck in an external location that is

corresponds approximately to the internal soft tissue of the associated individual

with the anterior triangle of the neck. The end may include a surface

adhesive Additionally, a vacuum pump inlet is provided for

receive a negative pressure in the chamber to apply a force to a surface of the

25 patient's neck to drag the surface towards the camera. The device

Pressure. In addition, a pressure control device is provided to control

the force applied in a spectrum between about 4.9 N and 65.5 N (0.5 kilograms a

about 6.68 kilograms). In some embodiments, the applied force is found

5

within a spectrum of between about 6 N and 60.2 N (0.61 kg to 6.14 kg). In others

realizations, the applied force is within a spectrum of between

7.25 N Y 55.4 N (0.74 kg to 5.65 kg). In some embodiments, the applied force is

finds within a spectrum of between about 8.9 N and 51 N (0.91 kg to 5.2 kg). In

some realizations, the applied force is within a spectrum of

the

about 10.9Ny46.9N (1.l1 kga4.78kg).

In some embodiments, the container is made of a material with

flexible memory, such as silicone, urethane or rubber.

In some embodiments, the pressure control device exerts the

negative pressure inside the inner chamber in a spectrum of between 7.62 Pa and

fifteen

60.96 Pa (7.62 cm at about 60.96 cm of water). In some embodiments, a container

is dimensionally adapted to define an interior chamber to cover the

anterior triangle from about 32.90 cm2 to about 210.58 cm2 of surface area.

In some embodiments, the device also includes a pump

dynamic. The dynamic pump can be a regenerative pump or a pump

twenty

Centrifugal In some embodiments, the device includes a pump

positive displacement. The positive displacement pump can be a

rotary pump, a diaphragm pump or a linear pump.

A method to apply a force to open a superior airway of

a patient can be as follows. The container is placed on a surface

of the patient's neck to seat one end under the patient's chin with the

soft internal tissue of the patient associated with the anterior triangle of the neck. A force is applied in a spectrum of between 4.9 N and 65.5 N (0.5 kilograms to about 6.68 kilograms) inside the chamber to attract the anterior triangle of the neck to the inner chamber. The container may be located on the anterior triangle of the patient's neck to treat obstructive sleep apnea of sleep and other disorders associated with obstruction of the superior airway.

One method to reduce snoring can be as follows. The container with the opening is placed on the surface of an individual's neck. The container is configured to fit under the chin of an individual adjacent to the neck of the individual at an external location corresponding approximately to the internal soft tissue of the individual associated with the anterior triangle of the neck. The container is fixed to the opening with a tube having a first end and a second end. The first end of the tube is connected to the opening. In addition, a vacuum source is connected to the second end of the tube. The vacuum source has a microprocessor and at least one acoustic sensor connected to it. A force is applied to the anterior triangle of the patient's neck in a spectrum of between 4.9 N and 65.5 N (0.5 kilograms to about 6.68 kilograms). A signal that corresponds to an acoustic signature of the individual is identified by the acoustic sensor. The signal is recorded and processed with a microprocessor connected to the vacuum source. The level of negative pressure created in the vacuum source is automatically maintained to reduce and / or eliminate snoring. In some embodiments, the acoustic sensor is a microphone.

In this way, some embodiments of the invention have been highlighted in order to provide a better understanding of the detailed description of the best one. There are additional embodiments of the invention which will be described below, and which will form the subject of the claims appended hereto.

In this regard, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components indicated in the following description or illustrated in the drawings. . The invention is capable of embodiments that must be added to those that have been described, and is capable of being practiced and carried out in different ways. Likewise, it should be understood that the phraseology and terminology used in this document, as well as in the summary, are solely for the purpose of description, and should not be considered as a limitation.

BRIEF DESCRIPTION OF THE DOWNLOADS

The present invention and the various advantageous features and details thereof are explained in more detail with reference to the non-limiting embodiments which are illustrated in the accompanying drawings and which are detailed in the following description. It should be noted that the features illustrated in the drawings are not necessarily drawn to scale. Descriptions of the well-known process components and techniques are omitted so as not to unnecessarily blur the present invention. The examples that are used in this document are only intended to facilitate the understanding of the ways in which the invention may be used, and to further assist those examples should not be considered as limiting the scope of the invention. In the drawings, like reference numbers designate corresponding parts throughout the different views.

The FrO. LA is a view of the device according to an embodiment of the present invention in an individual; The FrO. IB shows a perspective view of the device according to an embodiment of the present invention; The FrO. IC is an axial view of the FrO device. lA in an individual; The FrO. ID and IE are a sagittal view and a normal view of an individual's jaw, respectively; The FrO. I F and 10 are CT scans of a sagittal view and an axial view of the upper airway of an individual, respectively, at ambient pressure;

The FrO. IH and 1I are CT scans of a sagittal view and an axial view of the upper airway of an individual, respectively, to a vacuum of 51 centimeters of water;

The FrO. 2 is a sagittal view of an individual using the LaFrO device. the; The FrO. 3 is a detailed partial sectional view of the container according to an embodiment of the present invention; Fig. 4A is a view of the device according to an embodiment of the present invention in an individual; The FrO. 4B is an axial view of the FrO device. 4A in a

individual;

FIG. 4A; FIG. 6 is a schematic representation of an embodiment of the vacuum source according to the device of FIG. the.

Detailed description

The invention will now be described with reference to the drawn figures, in which similar reference numerals refer to similar parts along the same.

With reference to FIG. IA, a device 101 is shown in an individual 103 according to an embodiment of the present invention. The device 101 includes a container 105, a vacuum source 109, a tube III and a pressure control (not shown). The container 105, among other things, includes an end 107 and an internal surface (not shown). End 107 fits over the patient's chin and neck to define a chamber at an external location approximately in the internal soft tissue of the individual associated with the anterior triangle of the neck.

According to the embodiment shown in FIG. lA, a device 101 with a container 105 is carried by an individual. The container 105 is connected to a tube 111 at a first end 113 of the tube 111. A second end 115 of the tube 111 is fixed to a vacuum source 109. The container 105 is fixed to the individual 103 by a strip 117.

The container 105 can be a hollow or concave tool. In a non-limiting example, the container 105 may be cup-shaped, bowl-shaped or the like. The container can be formed, molded or manufactured from any material. Non-limiting examples of such suitable materials for building the container 105 include plastics, metals, natural fabrics, synthetic fabrics and the like. The container 105 can also be made from a material having an elastic memory, such as silicone, rubber or urethane.

Additionally, the container 105 can be flexible, semi-rigid or rigid. For the purposes of the present invention, "semi-rigid" means partial

or slightly stiff. "Flexible" means capable of being bent, usually without breaking it, or susceptible to modification or adaptation. "Rigid" means hard or inflexible, neither folding nor flexible.

As shown in Figure 1A, the strip 117 functions to fix and help seal the container OS on the surface of the skin of the individual 103. In alternative embodiments, the container 105 may be fixed on a surface of the neck of a individual by a negative pressure exerted by the vacuum source 109. Alternatively, adhesive may be used to secure the container 105 to the neck of the individual. Likewise, the natural anatomical contour of an individual can work synergistically with any other known fixation means, thereby increasing the effectiveness of fixation. In the same way, the natural anatomical contours of the individual can, by themselves, act to fix the container 105 to the surface of the individual's neck. All serve as sufficient means to fix the container 105 on the surface of the individual's neck.

In alternative embodiments, a seal can be created by, for example, an adhesive, the natural anatomical contours of the individual, or at least one clamp, such as a differential clamp, and the like. In one embodiment, end 107 has a high pressure contact zone with the skin

vacuum source 109, a seal is created. In alternative embodiments, the seal is created by applying an adhesive to the device 101 or to the skin of the neck of an individual in a desired area. In some embodiments, the seal may be an elastomeric seal. The elastomeric seal may comprise outer wings or extensions, or the like, attached to the container 105. In one embodiment, the elastomeric seal may be attached to the end 107. The elastomeric seal may be manufactured from materials including, but not limited to : Natural rubber (NR); Polyisoprene (IR); Butyl rubber (isobutylene e isoprene copolymer, I1R); Halogenated butyl rubber (Chlorobutyl rubber: CIIR; Bromobutyl rubber: BIIR); Polybutadiene (BR); Styrene-butadiene rubber (polystyrene-polybutadiene copolymer, SBR); Nitrile rubber (polybutadiene and acrylonitrile copolymer, NBR), also called Buna-N rubbers; Hydrated Nitrile Rubber (HNBR) Therban® and Zetpol®; Chloroprene rubber 15 (CR), polychloroprene, Neoprene, Bayprene; EPM (ethylene propylene rubber, polyethylene and polypropylene copolymer droppings) and EPDM rubber (ethylene propylene diene rubber, a terpolymer of polyethylene, polypropylene and a diene component); Epichlorohydrin rubber (ECO); Polyacrylic rubber (ACM, ABR); Silicone rubber (SI, Q, VMQ); Fluorosilicone rubber

20 (FVMQ); Fluoroelastomers (FKM, FPM), for example, Viton®, Tecnoflon®, Fluorel® and Dai-EI®; Perfluoroelastomers (FFKM); Tetrafluoro ethylene / propylene rubbers (FEPM); Chlorosulfonated polyethylene (CSM), (Hypalon®); Ethylene-vinyl acetate (EVA); Thermoplastic elastomers (TPE), for example, Hytrel®, Santoprene®; Polyurethane rubber; Resilin, Elastin; and Polysulfide rubber.

shown embodiment, the bellows 119 allows the individual 103 to maintain the natural movement of the head while allowing the container 105 to be effectively sealed with the skin of the individual 103. In one embodiment, the bellows

5 119 is formed from the same material as the container 105. In alternative embodiments, the bellows 119 may be formed from other suitable materials.

In a realization, the bellows 119 does not have stiffness in a lateral sense, in order to allow a greater movement of the individual. However, rigidity

The side of the bellows can vary depending on the desired lateral movement. As regards the rigidity of the circumference, the bellows 119 is rigid enough so that the container 105 does not collapse. In some embodiments, the container has no bellows.

FIG. lB shows an alternative embodiment of the device 101. The

The device 101 includes a container 105 and a tube 111. The container 105 includes an end 107 that sits under the individual's chin to define a chamber at an external location approximately in the internal soft tissue of the individual associated with the anterior triangle of the neck. . The container 105 covers the soft tissue of the anterior triangle of the individual's neck in a spectrum of between

20 approximately 32.9 cm2 and 210.58 cm2 • The spectrum can cover the anatomical variations of the user public. The end 107 helps seal the container 105 on the surface of the individual's skin and avoids the need for a strip. In this embodiment, negative pressure exerted by a vacuum source holds container 105 in place.

the FrG. The one about an individual. In the embodiment shown, the container 105 is placed against the surface of the skin 121 of the individual in the jaw 123 of the individual. A vacuum cavity 125 is created between the skin of the individual 121 and the inner surface 127 of the container. The vacuum cavity 125 allows the displacement of the soft tissue.

The vacuum source 109 creates a negative pressure that is transferred through the tube III to the container 105. Negative pressure means pressure below the atmospheric pressure. This negative pressure, in conjunction with the area delimited by the seal, applies a force, and therefore moves forward the soft tissues of the chin / neck, thus expanding the passage of the airway in the back of the throat. According to the embodiment shown, the negative pressure created by the vacuum source 109 exerts a negative pressure on a surface of the individual's skin.

The FrG. ID-IE show a few example dimensions of an individual's jaw. Given the dimensions, the area and soft tissue volume of the individual's jaw is about 32 cm2 and about 163 cm3, respectively. The weight of the soft tissue mass of the individual is about 0.17 kg. The pressure to counteract the soft tissue weight of the individual is about 7.6 Pa (7.6 cm of water). The maximum effective pressure may depend on the threshold of comfort of the individual.

In a preferred embodiment, the force accumulated in the spectrum of between 4.9 N to 65.5 N (between 0.5 kilograms and 6.68 kilograms) is applied to the interior of the container to pull the anterior triangle of the neck towards the inner chamber. The accumulated force can preferably be between about 6 N and about 60.2 N

about 7.25 N and about 55.4 N (between about 0.74 kilograms and about 5.65 kilograms) and

more preferably between about 8.9 N and 51 N (between about 0.91 kilograms and about 5.2

kilograms), and more preferably between about 10.9 N and 46.9 N (between about 1.11

5

kilograms and about 4.78 kilograms).

Figures 1 F -1 G show CT scans of the upper airway of the

Indi viduo at environmental pressure. Figures 1 H-11 show the CT scans of the

same individual with a negative pressure of 51 centimeters of vacuum water. Such

As shown in the figures, there is an appreciable increase in the gauge of the track

the

of superior air. The pressures below about 7.62 Pa (7.62 centimeters of

water) can be ineffective, since the pressure may be insufficient

to keep the container in the proper anatomical position. The pressures

applied above about 60.96 Pa (60.96 centimeters of water) of vacuum can

not be tolerable by the user, as they make it difficult to talk and swallow due to

fifteen

the high pressure.

The contact pressure applied to the individual's jaw varies in

function of the contact surface and the level of operational vacuum of the container. In

a determined negative pressure value, for example 60 Pa (60 centimeters of

water), increasing the contact surface between the container and the

twenty

individual, the contact pressure with the skin is reduced and can improve the level of

comfort of the individual.

The vacuum source 109 can be any type of vacuum pump

pneumatic, including a dynamic pump and a displacement pump

positive. In one embodiment, the dynamic pump can be a regenerative pump or

a centrifugal pump. The positive displacement pump can be a pump

Pneumatic vacuum pump can be any pump that creates a vacuum. In one embodiment, the pneumatic vacuum pump can provide up to 137 Pa (137 centimeters of water) of vacuum. Additionally, in one embodiment, the pneumatic vacuum pump can operate at a sound pressure of less than 25 dB. In another embodiment, the pneumatic vacuum pump does not create dynamic pressure waves. In a further embodiment, the pneumatic vacuum pump has a controller for regulating the level of vacuum transmitted. Preferably, the pneumatic vacuum pump contains all of these features.

The end 107 of the container 105 may be coated or covered with a means for contact with the skin of low pressure. In one embodiment, the low pressure skin contacting means is an air tube that traverses the perimeter of the container. When negative pressure is applied by the vacuum source 109, the contact medium with the low pressure skin will be slightly compressed. In one embodiment, the air tube is inflated with a fixed amount of air. In an alternative configuration, the air tube is inflated with the exhaust emitted by the pneumatic vacuum pump. Additionally, the contact medium with the low pressure skin could include without limitation a soft material, such as foam, rubber, fabric, adbesive and the like. Additionally, the end 107 may extend around the entire perimeter of the container 105 including around the bellows

119. In alternative embodiments, end 107 may not include a means for low pressure contact. The end 107 can simply be the perimeter of the material comprising the container 105 or the container 105 and the bellows 119.

In an alternative embodiment, the device 101 may have a self-adjusting feature or a controller that maintains the vacuum level just low enough to eliminate snoring and / or apnea. The pneumatic vacuum pump would have at least one acoustic sensor that would pick up the acoustic signature emitted by the user that it picks up on the tube 111. The acoustic sensor according to any of the embodiments of the present invention can be any acoustic sensor such as for example a microphone, or similar. In one embodiment, the acoustic sensor is located in the container 105 itself. In alternative embodiments, the acoustic sensor could be located at any point of the device 101. The signal processing would activate a microprocessor to adjust the pressure from the pneumatic vacuum pump to a desired level. The objective is to improve patient comfort by optimizing the level of negative pressure.

Moving to FIG. 2, a sagittal view of an individual is shown using the device of FIG. the. In the embodiment shown, the natural anatomical contour of the patient forms a seal with the container 105.

As shown in Figure 2, the container 105 has an opening

129. The first end 113 of the tube is fixed to the container 105 in the opening 129. Accordingly, as shown, negative pressure can be generated in the vacuum source (not shown) and transmitted through the tube 111. Negative pressure in the vacuum cavity causes a negative pressure to be exerted on the exposed skin area. Negative pressure displaces the soft tissue of the individual, which causes a stenosis or open air pathway. Accordingly, the individual 103 has an airway that is open and free of obstructions.

With reference to FIG. 3, a detailed partial sectional view of the device of FIG. 2. In the embodiment shown, a differential clamp 131 is attached to the spring 119. The container lOS forms a seal with the neck of the individual in a region of differential clamp 133. The differential clamp 131 has a low friction surface 135 which it helps to form the seal in a zone of differential clamp 133. The differential clamp 131 is only a means for contact with the skin of low pressure. In alternative embodiments, it is possible to use other clamps similar to differential clamps. Additionally, in alternative embodiments, an adhesive may cover the surface of the clamp. When a seal is created, a low pressure environment is created in the vacuum cavity 125.

The area of differential clamp 133 includes both the point at which the differential clamp 131 contacts the skin of the individual and the surface surrounding the point of contact. In the area of differential clamp 133 the contact pattern along the neckline of an individual moves downwards instead of aligning with the undulations of bellows 119. Since there is a negative or low pressure between the neck and the differential clamp 131 in the vacuum cavity 125, a natural force is transmitted on the low friction surface 135 towards the neck. Accordingly, in the area of differential clamp 133, the pattern of contact along the neckline of an individual moves in such a way that the natural hydraulic forces, or the difference of the pressures that exist in normal atmospheric pressure and the negative or low pressure that exists in the vacuum cavity 125 will create an additional load on the actual sealing point itself, where the low friction surface 135 makes contact with the individual's neck.

Moving to FIG. 4A, a view of a device 137 according to an embodiment of the present invention is shown in an individual. The device 137 has a container 139. The container 139 has an end 141, and an internal surface (not shown). The container 139 is configured to fit under the chin of an individual 143 adjacent the neck of the individual in a location associated with the anterior triangle of the neck.

The container 139 is made or formed from a material having elastic memory. As a result, the container returns to its normal shape or position after being bent, compressed or stretched. The container 139 can be made of any material having elastic memory, including, without limitation, plastics, metals, fabrics, polymers, rubbers and the like.

An adhesive (not shown) coats at least a portion of the inner surface 147 of the container 139 to form a seal on the skin 145 of an individual 143.

Next, referring to FIG. 4B, this shows an axial view of the device of FIG. 4A about an individual. In the embodiment shown, the container 139 is placed on the surface of the skin 145 of the individual in the jaw 147 of the individual. An adhesive covers at least a portion of the inner surface 149 of the container 139.

In the embodiment shown in Figure 4B, a process for applying the container 139 comprises applying pressure on the outer surface 151 of the container 139 to an approximately central point of the container 139, causing it to reverse. The inverted container 139 is placed under the chin of the individual 143 adjacent the neck of the individual at an external location corresponding approximately to the internal soft tissue of the individual associated with the anterior triangle of the neck. After placing it on the subject, the pressure applied to the center point of the container 139 is removed so that the flexible container returns to its original shape, thereby holding the skin 145 in contact with the adhesive. As the internal soft tissue of the individual is displaced forward and downward, thereby improving the airway.

According to another embodiment of the present invention, the container 139 can be provided without any adhesive therein. Accordingly, the adhesive could be applied independently to the skin 145 of the individual 143 on a desired surface and the container 139 could be applied to the skin coated in the manner indicated above. In one embodiment, the adhesive could be double-sided tape.

Moving to FIG. 5, a sagittal view of an individual using the device of FIG. 4A. The container 139 has an adhesive on at least a portion of its inner surface 149. In contact with the skin, the container 139 pulls the skin of the individual. In this way the soft tissue of the individual is displaced, which causes an open stenosis. As a result, the individual 143 has an airway that is open and free of obstructions.

With reference to FIG. 6, a schematic representation of an embodiment of the vacuum source according to the device of FIG. the. In the embodiment shown, the vacuum source 109 has a vacuum pump 153 attached to a motor 155. A microcontroller 157, such as a microprocessor, is fixed to the motor by a first electrical connection 159. A pressure sensor 161 is fixed to the microcontroller 157 through a second electrical connection

163. Likewise, a tube 111 connects the container (not shown) with the vacuum pump at the opposite ends of the tube 111. A first pneumatic connection 165 fixes the tube 111 to the pressure sensor 161. A discharge valve 167 is fixed to the tube 111 by a second pneumatic connection 169.

Vacuum 153 can be any type of pneumatic vacuum pump, including, without limitation, a regenerative pump, a rotary pump, a diaphragm pump, a centrifugal pump, a positive displacement pump or a dynamic pump. In one embodiment, the pneumatic vacuum pump can provide a vacuum of up to 137 cm of water. The microcontroller 157 may be any controller capable of identifying and processing data and / or signals received from the motor 155 and the vacuum pump 153 and / or the pressure sensor 161 to regulate the vacuum pressure or negative pressure generated. The discharge valve 167 can be operated mechanically or manually. The discharge valve is used to control or limit the negative pressure exerted by the motor 155 and the vacuum pump 153 that can accumulate, allowing pressure to flow therefrom.

In accordance with an embodiment of the present invention, a user establishes an initial vacuum level of the device. Until the container 109 is in place and connected in a desired position, the pressure sensor 163 will recognize the low vacuum levels. The microcontroller 157 will accelerate the motor 155 and the vacuum pump 153 until a certain vacuum value or a desired level of negative pressure is reached in the vacuum cavity (not shown) of the container (not shown). If a vacuum value or a desired negative pressure level is exceeded, the microcontroller 157 will electrically brake the motor 155 and the vacuum pump 153. The set vacuum level or the desired level of negative pressure is automatically maintained by the microcontroller. To compensate for leaks in the system, the motor 155 and the vacuum pump 153 will rotate slowly, thus compensating for leaks in the system. Therefore, the device will operate silently.

devices to open an airway.

According to a method for opening an airway, a device is placed on the surface of an individual's neck. The device has a container with an end and an internal surface. The device is configured to fit under the chin of an individual adjacent to the neck of the individual at an external location corresponding approximately to the internal soft tissue of the subject associated with the anterior triangle of the neck. The device applies negative pressure on the surface of the neck of the individual, thus opening the airway. The device is preferably a device as described herein with respect to other embodiments of the present invention.

According to another method for opening an airway, a container is placed on the surface of an individual's neck. The container has an end and an internal surface. The container is configured to fit under the chin of the individual adjacent to the neck of the individual in an external location that approximately corresponds to the internal soft tissue of the individual associated with the anterior triangle of the neck. The container is connected to a source of negative pressure. A force is applied in a spectrum between about 4.9 N and about 65.5 N (between about 0.5 kilograms and about 6.68 kilograms) on the anterior triangle of the neck of the individual to pull the soft tissue into the inner chamber. The device is preferably a device as described herein with respect to other embodiments of the present invention.

According to another method for opening an airway, a flexible container with elastic memory is provided with an end, an inner surface, a

less partially with an adhesive. By applying pressure on the outer surface at the center point of the flexible container, it is inverted. The inverted flexible container is placed under the chin of an individual adjacent to the neck of the individual 5 in an external location that approximately corresponds to the internal soft tissue of the individual associated with the anterior triangle of the neck. The pressure applied to the center point of the flexible container is removed so that the flexible container returns to its original shape. The device is preferably a device as described herein with respect to other embodiments of

10 the present invention.

One method to reduce snoring can be as follows: a container with an opening is placed on the surface of an individual's neck. The container is configured to fit under the chin of an individual adjacent to the neck of the individual in an external location that corresponds

15 approximately with the internal soft tissue of the individual associated with the anterior triangle of the neck. The receiver is connected in its opening with a tube having a first end and a second end. The first end of the tube is connected to the opening. Also, a vacuum source is connected to the second end of the tube. The vacuum source has a microprocessor and at least one sensor

20 acoustic connected with it. Negative pressure is created in the vacuum source. A signal that corresponds to an acoustic signature of the individual is identified by the acoustic sensor. The signal is recorded and processed with a microprocessor connected to the vacuum source. The pressure level created in the vacuum source is maintained automatically to reduce and / or eliminate the

Claims (9)

A therapeutic device for relieving the obstruction of a patient's upper airway, comprising: 5 a container (105) with an end (107) AND an internal surface, in which the end (107) is configured to settle on the patient's chin and neck to define a chamber (125) at an external location approximately in the internal soft tissue of the patient (103) associated with the anterior triangle of the neck; a pump input 10 vacuum to receive a negative pressure in the chamber (125) to apply force to a surface of the patient's neck (103) to draw the surface into the chamber (125); and a control device for controlling the applied force in a spectrum of between about 4.9 N (0.5 kg) and about 65.5 N (6.68 kg) characterized in that the end (107) comprises an elastomeric seal with wings or extensions external and when the apparatus is applied to the patient (103), the contact pressure applied to the patient's jaw (123) depends on its contact area and the contact area increases with the level of 20 vacuum applied. 2. A therapeutic apparatus according to claim 1, wherein the applied force is in a spectrum of between about 6 N to 60.2 N (0.61 kg to 6.14 kg), or in which the applied force is in a spectrum between about 7.25 N to 55.4

3.

A therapeutic apparatus according to claim 1, which also includes a tube (111) for connecting the container (105) to the pressure control device.

Four.

A therapeutic apparatus according to claim 1, wherein the pressure control device exerts a negative pressure inside the inner chamber (125) in a spectrum of between about 7.62 Pa and 60.96 Pa (7.62 cm to 60.96 cm of water).

5.

A therapeutic apparatus according to claim 1, wherein the container

(105) is dimensionally adapted to define an interior chamber (125) to cover the anterior triangle of between about 32.90 cm2 and about 210.58 cm2 of surface area. 6. A therapeutic apparatus according to claim 1, wherein the end (107) includes an adhesive surface. 7. A therapeutic apparatus according to claim 1, wherein the container (105) comprises a material with elastic memory, and preferably comprises silicone, urethane or rubber.

8

A therapeutic apparatus according to claim 1, which also includes a dynamic pump, in which the dynamic pump preferably comprises a regenerative pump or a centrifugal pump.

9

A therapeutic apparatus according to claim 1, which also includes a positive displacement pump, wherein the positive displacement preferably comprises a rotary pump, a diaphragm pump or a linear pump.